MAUDE Adverse Event Report: THORATEC CORPORATION HMII, G2.3, POCKET CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number	10005080
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patients waveforms were sent for review.The data showed numerous pump stops and low speed advisories between (b)(6) 2021 and (b)(6) 2021.There were no other unusual events recorded in log file history.There was potential concern for an area where the shielding appeared to be worn down.On (b)(6) 2021 the patient received a pump exchange.Related manufacturer report number: 2916596-2021-06285.
Additional Manufacturer Narrative
Manufacturer investigation conclusion: the reported event of numerous pump stops and low speed advisories between (b)(6) 2021 and (b(6) 2021 was confirmed via the submitted log file.The submitted log file (labeled aa190937) contained data spanning approximately 5 days ((b)(6) 2021 ¿ (b)(6) 2021 per the timestamp).The log file captured several pump stops and low speed advisory and hazard alarms in the log file.This is addressed via the pump investigation (pi-2021-0175353-01).Additionally, the heartmate ii g2.3 pocket controller (serial number (b)(4) ) was returned to abbott burlington.The controller underwent preliminary testing; however, the controller could not complete the preliminary and functional testing due to the controller being damaged beyond repair.The controller was dissected and there was a white fluid contaminate covering the majority of the printed circuit board and inside cover of the controller.There was also corrosion in the bulkhead assembly and power cable pins.The controller could not be connected to a test pump due to the corrosion in the bulkhead assembly impeding the connection of the driveline.The root cause of the reported event could not be conclusively determined through this analysis; however, fluid ingress could have contributed to the reported event.The device history records were reviewed and the records revealed the heartmate ii g2.3 pocket controller (serial#: (b)(4) ) was manufactured in accordance with manufacturing and qa specifications.(b)(4) was shipped to the customer on (b)(6) 2020.Heartmate ii instructions for use (rev.C) section 7 ¿ ¿alarms and troubleshooting¿ and heartmate ii patient handbook (rev.C) section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (auditory and visual), including the power cable disconnect alarm conditions, low voltage advisory alarm conditions, and the actions to take if the issue does not resolve.The heartmate ii patient handbook (rev.C, section 10 ¿safety checklists¿) instructs users to regularly inspect their equipment for damage, and to obtain replacements if needed.Heartmate ii instructions for use (rev.C) section 8-¿equipment storage and care¿ and heartmate ii patient handbook (rev.C) section 6-¿caring for the equipment¿ explain how to properly maintain the integrity of the system controller.The patient handbook and the instructions for use caution the user to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
Manufacturer investigation conclusion: the reported event of numerous pump stops and low speed advisories between (b)(6) 2021 and (b(6) 2021 was confirmed via the submitted log file.The submitted log file (labeled (b)(4)) contained data spanning approximately 5 days ((b)(6) 2021 ¿ (b)(6) 2021 per the timestamp).The log file captured several pump stops and low speed advisory and hazard alarms in the log file.This is addressed via the pump investigation ((b)(4)).Additionally, the heartmate ii g2.3 pocket controller (serial number (b)(4)) was returned to abbott (b)(4).The controller underwent preliminary testing; however, the controller could not complete the preliminary and functional testing due to the controller being damaged beyond repair.The controller was dissected and there was a white fluid contaminate covering the majority of the printed circuit board and inside cover of the controller.There was also corrosion in the bulkhead assembly and power cable pins.The controller could not be connected to a test pump due to the corrosion in the bulkhead assembly impeding the connection of the driveline.The root cause of the reported event could not be conclusively determined through this analysis; however, fluid ingress could have contributed to the reported event.The device history records were reviewed and the records revealed the heartmate ii g2.3 pocket controller (serial#: (b)(4) ) was manufactured in accordance with manufacturing and qa specifications.(b)(4) was shipped to the customer on (b)(6) 2020.Heartmate ii instructions for use (rev.C) section 7 ¿ ¿alarms and troubleshooting¿ and heartmate ii patient handbook (rev.C) section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (auditory and visual), including the power cable disconnect alarm conditions, low voltage advisory alarm conditions, and the actions to take if the issue does not resolve.The heartmate ii patient handbook (rev.C, section 10 ¿safety checklists¿) instructs users to regularly inspect their equipment for damage, and to obtain replacements if needed.Heartmate ii instructions for use (rev.C) section 8-¿equipment storage and care¿ and heartmate ii patient handbook (rev.C) section 6-¿caring for the equipment¿ explain how to properly maintain the integrity of the system controller.The patient handbook and the instructions for use caution the user to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the patients waveforms were sent for review.The data showed numerous pump stops and low speed advisories between (b)(6) 2021 and (b)(6) 2021.There were no other unusual events recorded in log file history.There was potential concern for an area where the shielding appeared to be worn down.On (b)(6) 2021 the patient received a pump exchange.Related manufacturer report number: 2916596-2021-06285.

• Brand Name: HMII, G2.3, POCKET CONTROLLER
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13366819
• Report Number: 2916596-2022-00569
• Device Sequence Number: 5304029
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Model Number: 10005080
• Device Catalogue Number: 10005080
• Device Lot Number: 6531787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 107 KG